Analytical Development - Manager / Sr. Manager

BridgeBio Pharma; United States; On-site; USD 163,800 - 177,400; Full time

Benefits offered by this job

401(k) with employer match

Employee Stock Purchase Program (ESPP)

100% employer-paid medical, dental, and vision premiums

Flexible paid time off

Hybrid work model

Job summary

BridgeBio Pharma seeks a Senior Manager, Analytical Development to lead the Analytical Development Team. This role involves overseeing contract organizations, managing analytical documentation, and supporting CMC regulatory submissions for Phase III clinical trials.

The ideal candidate will have over 7 years in analytical development, leadership experience, and proficiency in analytical techniques. Benefits include compensation packages, health insurance, and a hybrid work model.

Qualifications

• 7 years of experience in a pharmaceutical setting.
• Proven leadership experience managing analytical chemists.
• Proficient in various analytical techniques.

Responsibilities

• Oversee contract development and manufacturing organizations.
• Manage analytical documentation within QMS.
• Support and author CMC regulatory dossiers.

Skills

Analytical techniques (HPLC, LC/MS, etc.)

Leadership in analytical development

Knowledge of CMC regulatory requirements

Effective communication with vendors

Project management

Education

7+ years in analytical development

Job description

Senior Manager, Analytical Development

The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials through commercial activities. Candidates will work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs.

Responsibilities

• Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP).
• Manage analytical documentation (CofAs, test methods, protocols, reports, specifications, stability, raw data) within Quality Management System (QMS).
• Support and author analytical content for CMC regulatory dossiers for U.S. and rest of world.
• Manage GMP stability studies and provide trend analysis in support of retest and shelf‑life extension.
• Manage reference standard program (qualification, storage, inventory, distribution).
• Develop and approve specifications for raw materials, intermediates, and finished product and apply regulatory requirements to specifications.
• Develop and validate analytical methods and verify compendial methods.
• Communicate results internally and externally through oral and written updates and formal reports as necessary.
• Provide analytical support for API and Drug Product process development.
• Author development reports, protocols, and methods.
• Support quality audits as a technical representative and contribute to authoring of audit reports.

Education, Experience & Skills Requirements

• At least 7 years of experience in analytical development in a pharmaceutical setting.
• Proven leadership experience managing analytical chemists at various levels externally (CMO management).
• Proficient in analytical techniques and regulatory areas including HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and appropriate analytical method validation.
• Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and responses to regulatory inquiries; experience applying ICH, FDA, EMA guidelines to pharmaceutical development and CMC strategy.
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
• Ability to understand project timelines and prioritize activities to achieve project goals.
• Capacity to adapt to changes in priorities on short notice and make independent decisions under tight timelines.
• Travel up to 20%.

Salary Range (California)

$163,800 — $177,400 USD

Benefits

• Market‑leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre‑tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in‑office days
• 100% employer‑paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family‑forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, “take‑what‑you‑need” paid time off and company‑paid holidays
• Comprehensive paid medical and parental leave

Skill Development & Career Paths

• Opportunities for skill development and internal mobility from discovery through FDA pipelines.
• Career pathing through regular feedback and continuous education programs via LinkedIn Learning, LifeLabs, and BetterUp Coaching.
• Recognition of strong performance with financial rewards, peer‑to‑peer recognition, and growth opportunities.